Observational Study in Real Life to Describe the Libicare® Effectiveness in Female Sexual Dysfunction.

NCT04124640 | Completed

• 1 other identifier: PRO-LIB-2019-01
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

The decrease or absence sexual desire and arousal is the alteration of the sexual sphere that women most commonly refer to in adulthood and old age. Many women can refer a decrease or absence of desire and / or arousal without having the disorder typified in the DSM-5, but that can cause discomfort, worry and relationship problems in their day to day. Libicare® is a food supplement whose ingredients could have positive effects on the improvement of sexual function in women with low desire and arousal levels. The main ingredients of Libicare® are:

• Trigonella Foenum-graecum (Trigonella) (1)
• Tribulus Terrestris (Tribulus) (2)
• Turnera Diffusa (Damiana) (3)

Conditions

Female Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• To describe the effectiveness of LIBICARE® in improving sexual desire and arousal in women between 45 and 65 years of age, in real life.

  The effectiveness will be the increase in the score of the EVAS-M scale that will be provided to patients in the visita during the follow-up visits.

  4 month

Secondary Outcomes (6)

• Evaluation of the 6 domains of the EVAS-M scale at 2 and 4 months of treatment.

  at 2 and 4 months of treatment

• Evaluation of the safety of LIBICARE® by collecting serious and non-serious adverse events.

  at 4 months of treatment

• Evaluation of patient satisfaction with treatment at 2 and 4 months of treatment.

  at 2 and 4 months of treatment

• Therapeutic compliance in taking the food supplement at 2 and 4 months of treatment.

  at 2 and 4 months of treatment

• Study of the hormonal variation in relation to the values of total testosterone, free testosterone and SHBG, at the beginning, at 2 months and at 4 months of treatment, in those patients in which it is determined by routine clinical practice.

  at 0, 2 and 4 months of treatment

Study Arms (1)

treatment group

The study population will be women between 45 and 65 years old, both ages included, who present a decrease in sexual desire or arousal

Other: Patients' data (baseline characteristics, clinical and outcomes) from routine care visits

Interventions

Patients' data (baseline characteristics, clinical and outcomes) from routine care visits OTHER

Use of a standardized scale to collect clinical and patient-centered data, to assess the effectiveness of Libicare in real life in female 45-65 years old. Patients' data (baseline characteristics, clinical and outcomes) will be collected according to sites routine care.

treatment group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be women between 45 and 65 years old, both ages included, who present a decrease in sexual desire or arousal

You may qualify if:

• Women between 45 and 65 years old, both ages included.
• Women who refer decreased desire and / or sexual arousal.
• Women who will receive LIBICARE® by prescription of their doctor regardless of their participation or not in the study.
• Women who have given their informed consent in writing.

You may not qualify if:

• Women who suffer or have suffered breast cancer.
• Women in anticoagulant treatment.
• Women who, in the opinion of the researcher, cannot follow the study procedures.
• Women not be able to understand the nature of the study, the procedures to follow or who are not authorized to sign an informed consent
• Pregnant or lactating women
• Women with allergies to any of the components of Libicare®

Sponsors & Collaborators

• Procare Health Iberia S.L.: lead

Study Sites (1)

Instituto Palacios de Salud y Medicina de la Mujer

Madrid, 41720, Spain

Location

Related Publications (3)

• Rao A, Steels E, Beccaria G, Inder WJ, Vitetta L. Influence of a Specialized Trigonella foenum-graecum Seed Extract (Libifem), on Testosterone, Estradiol and Sexual Function in Healthy Menstruating Women, a Randomised Placebo Controlled Study. Phytother Res. 2015 Aug;29(8):1123-30. doi: 10.1002/ptr.5355. Epub 2015 Apr 24.

  PMID: 25914334 RESULT

• Akhtari E, Raisi F, Keshavarz M, Hosseini H, Sohrabvand F, Bioos S, Kamalinejad M, Ghobadi A. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study. Daru. 2014 Apr 28;22(1):40. doi: 10.1186/2008-2231-22-40.

  PMID: 24773615 RESULT

• Zhao J, Dasmahapatra AK, Khan SI, Khan IA. Anti-aromatase activity of the constituents from damiana (Turnera diffusa). J Ethnopharmacol. 2008 Dec 8;120(3):387-93. doi: 10.1016/j.jep.2008.09.016. Epub 2008 Sep 26.

  PMID: 18948180 RESULT

MeSH Terms

Interventions

Treatment Outcome

Intervention Hierarchy (Ancestors)

Prognosis; Diagnosis; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Study Officials

• Josep Combalia, MD

  Procare health Iberia

  STUDY DIRECTOR

• Santiago Palacios

  Instituto Palacios de Salud y Medicina de la Mujer.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: October 11, 2019
• Study Start: October 29, 2019
• Primary Completion: December 31, 2020
• Study Completion: November 15, 2021
• Last Updated: December 2, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)